Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urticaria
Intervention: levocetirizine dihydrochloride (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Isabelle Campine, Study Director, Affiliation: UCB
Summary
Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic
Idiopathic Urticaria.
Clinical Details
Official title: A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Chronic Idiopathic Urticaria (CIU)
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Primary outcome: pruritus severity, assessed by the investigator over 2 weeks of treatment
Secondary outcome: Symptom score reducing index; subject severity score at 1 and 2 weeks; investigator global evaluation after 2 weeks of treatment; safety
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female, 18 to 60 years old (inclusive
- having chronic idiopathic urticaria
- at least 6-weeks history of CIU, had at least 3 days of wheals presence/week
- moderate to severe CIU defined as pruritus score ≥ 2, number of wheals ≥ 2, and total
symptoms CIU score ≥ 2 at randomization
Exclusion Criteria:
- Asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
- atopic dermatitis or urticaria requiring an antihistamine treatment or the
administration of oral or dermal topical corticosteroids
- urticaria caused by physical factors or other known factors
- cholinergic urticaria
- had urticaria due to other systemic disorders
- were on antihistamine drug currently
Locations and Contacts
Additional Information
Starting date: August 2003
Ending date: March 2004
Last updated: March 6, 2008
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